The Clinical Evaluation of the Cinatra™ Corolimus-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries

NCT01025869 | Terminated DMC

• 1 other identifier: 902
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 4

Brief Summary

To investigate the safety and efficacy of the Cinatra™ Corolimus Drug Eluting Stent for the treatment of de novo lesions in native coronary arteries.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• In-stent late lumen loss (LLL) as measured by quantitative coronary angiography (QCA).

  6 months post treatment

Secondary Outcomes (13)

• Target lesion revascularization

  1, 6 and 18 month and annually to 5 years

• Target vessel revascularization

  1 month and at all follow up to 5 years

• Stent thrombosis

  All follow ups

• Neointimal Hyperplasia

  6 and 18 months

• Binary restenosis

  6 and 18 months

Study Arms (1)

Stent System

OTHER

Cinatra™ Corolimus Eluting Coronary Stent System

Device: Cinatra™ Corolimus Eluting Coronary Stent System

Interventions

Cinatra™ Corolimus Eluting Coronary Stent System DEVICE

Stent implantation

Stent System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥ 18 years old
• Patient is an acceptable candidate for percutaneous coronary intervention (PCI), stenting, and emergent coronary artery bypass graft (CABG) surgery
• Patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, and/or a positive functional study
• Female subjects of childbearing potential must have a negative pregnancy test within 7 days before the trial procedure
• Patient or subject's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Hospital Research Ethics Committee (HREC) of the respective investigational site
• Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed
• Angiographic:
• Patient has either a single target lesion, or two lesions (target and non-target) located in separate coronary arteries
• If a non-target lesion is treated, it must be treated first and only with commercially available PTCA balloons and/or stents. Post PCI of the non-target vessel, all of the following conditions must be met:
• Residual diameter stenosis \<10%
• Absence of any angiographic complications
• Absence of ischaemic symptoms
• Absence of significant new arrhythmia or ECG monitoring changes suggestive of ischaemia
• Target lesion must be a de novo lesion in native coronary artery
• Target lesion must be ≤ 22 mm in length

You may not qualify if:

• Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, chromium, stent coatings (i.e. fatty acids, glycerides, and alpha tocopherol), or a sensitivity to contrast media, which cannot be adequately pre-medicated
• History of an allergic reaction or significant sensitivity to drugs such as , zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
• Platelet count \< 100,000 cells/mm³ or \> 700,000 cells/mm³, or a white blood cell (WBC) count \< 3,000 cells/mm³ within 7 days prior to index procedure
• Serum creatinine level 170 micromol/L within 7 days prior to index procedure
• Evidence of an acute myocardial infarction (MI) within 72 hours of the intended trial procedure (defined as: Q wave myocardial infarction (QWMI) or non-Q wave myocardial infarction (NQWMI) having CK enzymes \> 2X the laboratory upper limit of normal with the presence of an elevated CK-MB (any amount above the laboratory upper limit of normal)
• Previous PCI of the target vessel within 9 months prior to the procedure
• Any planned additional PCI procedure within 30 days post-index procedure and/or planned PCI of the target vessel within 12 months post-procedure
• During the index procedure, the target and/or non-target lesion(s) requires treatment with a device other than PTCA prior to stent placement (including, but not limited to, cutting balloon, atherectomy, thrombectomy, etc.)
• Left ventricular ejection fraction (LVEF) \< 30% if evaluated, or clinical evidence of significant congestive heart failure (NYHA Class III or IV) within the prior 30 days
• History of a stroke or transient ischemic attack (TIA) within the prior 6 months
• Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
• History of bleeding diathesis or coagulopathy or will refuse blood transfusions
• Concurrent medical condition with a life expectancy of less than 12 months
• Any previous treatment of the target vessel(s) for restenosis, including brachytherapy
• \. Any condition which, in the Investigator's opinion, may interfere with the subject's optimal participation in the study 17. Currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures

Sponsors & Collaborators

• Atrium Medical Corporation: lead

Study Sites (4)

Auckland City Hospital

Auckland, New Zealand

Location

Mercy Angiography

Auckland, New Zealand

Location

North Shore Hospital

Auckland, New Zealand

Location

Christchurch Hospital

Christchurch, New Zealand

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• John Ormiston, MD

  Associate Professor and Interventional Cardiologist at Auckland City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 4, 2009
• Study Start: December 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: March 1, 2012
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

NZ (4)